title: Phase II study of semisynthetic paclitaxel in metastatic breast cancer.
abstract: The aim of this phase II study was to characterise the efficacy and toxicity of semisynthetic paclitaxel in patients with metastatic breast cancer. Eligible patients had measurable disease and had been treated with one prior chemotherapy regimen either as adjuvant or for metastatic disease. Semisynthetic paclitaxel was given at a dose of 175 mg/m2 over 3 h every 21 days with dexamethasone, cimetidine and diphenhydramine premedications. 31 patients were entered. All were evaluable for toxicity. 30 patients were evaluable for response because 1 patient was lost to follow-up after receiving one cycle. One patient achieved a complete response and 10 patients achieved partial responses for an overall response rate (CR + PR) of 37% (95% confidence interval 20-56%). 17 patients (55%) experienced at least one episode of grade 3 or 4 neutropenia. There were two episodes of febrile neutropenia complicating 155 cycles of therapy. One of these resulted in a treatment-related death in a patient with pulmonary metastasis. 3 patients required dose reductions for grade 3 sensory neuropathy. Our study shows that the antitumour activity and toxic effects of semisynthetic paclitaxel appear to be identical to the naturally occurring product.
authors.affiliation: Department of Medicine, Memorial Sloan-Kettering Cancer Center, New York, New York 10021, USA.
authors.forename: C
authors.initials: C
authors.lastname: Hudis
authors.forename: L
authors.initials: L
authors.lastname: Riccio
authors.forename: F
authors.initials: F
authors.lastname: Holmes
authors.forename: A
authors.initials: A
authors.lastname: Seidman
authors.forename: J
authors.initials: J
authors.lastname: Baselga
authors.forename: V
authors.initials: V
authors.lastname: Currie
authors.forename: D
authors.initials: D
authors.lastname: Fennelly
authors.forename: T
authors.initials: T
authors.lastname: Gilewski
authors.forename: M
authors.initials: M
authors.lastname: Moynahan
authors.forename: G
authors.initials: G
authors.lastname: Raptis
authors.forename: N
authors.initials: N
authors.lastname: Sklarin
authors.forename: A
authors.initials: A
authors.lastname: Surbone
authors.forename: M
authors.initials: M
authors.lastname: Uhlenhopp
authors.forename: N
authors.initials: N
authors.lastname: Maickel
authors.forename: T J
authors.initials: TJ
authors.lastname: Yao
authors.forename: S
authors.initials: S
authors.lastname: Hellmann
authors.forename: J
authors.initials: J
authors.lastname: Usakewicz
authors.forename: G
authors.initials: G
authors.lastname: Hortobagyi
authors.forename: L
authors.initials: L
authors.lastname: Norton
mesh_terms: D000328:Adult; D000368:Aged; D000972:Antineoplastic Agents, Phytogenic / Q000009:adverse effects / Q000138:chemical synthesis / Q000627:therapeutic use*; D001943:Breast Neoplasms / Q000188:drug therapy* / Q000473:pathology; D005260:Female; D006402:Hematologic Diseases / Q000139:chemically induced; D006801:Humans; D008875:Middle Aged; D009362:Neoplasm Metastasis; D017239:Paclitaxel / Q000009:adverse effects / Q000138:chemical synthesis / Q000627:therapeutic use*; D016896:Treatment Outcome
chemical_list: D000972:Antineoplastic Agents, Phytogenic; D017239:Paclitaxel